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Assist in the compounding activities inside classified areas. Remain gowned inside an ISO 7 environment for 6+ hrs.
Job Responsibility:
Assist in the compounding activities inside classified areas
Remain gowned inside an ISO 7 environment for 6+ hrs
Responsible for assisting in the set-up of daily activities including staging of batches, equipment cleaning and set-up, and documenting in batch records and logbooks
Meet Right First Time (RFT) metrics by reducing error / deviations and completing corrections in a timely manner
Maintain adherence to SOP’s, cGMPs and the manufacturing schedule
Aid in inventory control by properly documenting components and materials used on corresponding paperwork
Ability to receive and maintain a high-level gowning and media fill qualification
Independently assist and compound all production batches
Ability to troubleshoot equipment and compounding problems and escalate to management when required
Excellent documentation skills and high level of aseptic skill
Be able to complete periods of standing up to 6hrs per shift and be able to twist and lift product material during job shift
Assume other duties and responsibilities as directed by supervisor
Requirements:
A strong understanding of cGMP and GDP in a manufacturing setting required
Gowning experience required
Aseptic experience required
Excellent punctuality and attendance
Quality minded and detail oriented
Nice to have:
VLFH experience preferred
What we offer:
Competitive salary
Comprehensive benefits
Performance package
Ability to be part of an international leader in an expanding industry